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NDC 68788-9814-01 Terbinafine Hydrochloride 1 g/100g Details
Terbinafine Hydrochloride 1 g/100g
Terbinafine Hydrochloride is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred Pharmaceuticals, Inc. The primary component is TERBINAFINE HYDROCHLORIDE.
Product Information
| NDC | 68788-9814 |
|---|---|
| Product ID | 68788-9814_41b23666-e3a2-4367-82db-fcd5bb056d5e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Terbinafine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Terbinafine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | TERBINAFINE HYDROCHLORIDE |
| Labeler Name | Preferred Pharmaceuticals, Inc |
| Pharmaceutical Class | Allylamine Antifungal [EPC], Allylamine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077511 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68788-9814-01 (68788981401)
| NDC Package Code | 68788-9814-1 |
|---|---|
| Billing NDC | 68788981401 |
| Package | 15 g in 1 TUBE (68788-9814-1) |
| Marketing Start Date | 2012-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |